Takeda’s Successor Drug to Actos Fails to Win Approval

April 26 (Bloomberg) -- Takeda Pharmaceutical Co., Asia’s
biggest drugmaker, failed to win clearance to sell its new
diabetes treatment in the U.S., with regulators asking for more
information on the use of the medicine in other countries.

The request came in a so-called complete response letter
from the Food and Drug Administration, Osaka, Japan-based Takeda
said in a statement today. The necessary data can be supplied
from information collected outside the U.S. and from patient
studies under way, the company said.

The rejection of the drug, known chemically as alogliptin,
to treat type-2 diabetes, derails Takeda President Yasuchika
Hasegawa’s plan for it to be a new revenue generator when its
best-selling diabetes treatment Actos loses patent protection in
four months. The application was initially rejected in 2009,
when the FDA asked for more data on cardiovascular risks.

“We will immediately request a meeting with the FDA to
determine the appropriate next steps and are committed to
addressing outstanding issues,” Thomas Harris, Takeda’s vice
president of regulatory affairs, said in the statement. “We
remain confident in the benefit that alogliptin will bring to
patients with type 2 diabetes in the U.S., if approved.”

Takeda rose 0.6 percent to close at 3,550 yen in Tokyo
trading. The shares have lost half of their value in the past
five years, partly because of drug development failures.

Annual sales of alogliptin will probably reach 150 billion
yen ($1.8 billion) in five years, according to SMBC Nikko
Securities Inc. Actos generated $4.5 billion in sales for Osaka,
Japan-based Takeda last fiscal year, accounting for 27 percent
of revenue.

Approval Delays

The drugmaker initially applied to the FDA in December 2007
for approval to sell alogliptin. In June 2009, Takeda was told
its clinical data was insufficient based on new guidelines on
diabetes treatments and cardiovascular risks released in
December 2008. Takeda conducted additional studies for its
resubmission.

In the U.S., 25.8 million children and adults, or 8.3
percent of the population, have diabetes, including 7 million
people who are undiagnosed, according to the American Diabetes
Association’s Website. Cardiovascular disease and stroke are the
complications patients can have as consequences of diabetes, the
association said.

Diabetes is caused by the body’s inability to use or
produce the hormone insulin. It can lead to heart disease,
kidney failure, blindness or amputations. Most people have the
Type 2 form linked to being overweight or inactive.

Alogliptin is approved in Japan and sold under the brand
name of Nesina.